Trials / Terminated
TerminatedNCT02497612
To Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of a Single Dose Regimen of Ferroquine and Artefenomel in Adults and Children With Uncomplicated Plasmodium Falciparum Malaria
A Randomized, Double-blind, Phase IIb Study to Investigate the Efficacy, Safety, Tolerability and Pharmacokinetics of a Single Dose Regimen of Ferroquine (FQ) With Artefenomel (OZ439) in Adults and Children With Uncomplicated Plasmodium Falciparum Malaria
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 377 (actual)
- Sponsor
- Sanofi · Industry
- Sex
- All
- Age
- 6 Months – 69 Years
- Healthy volunteers
- Not accepted
Summary
Primary Objective: To determine whether a single dose combination of OZ439 (Artefenomel)/FQ (Ferroquine) was an efficacious treatment for uncomplicated Plasmodium falciparum malaria in adults and children. Secondary Objectives: * To evaluate the efficacy of OZ439/FQ: * To determine the incidence of recrudescence and re-infection. * To determine the time to relief of fever and parasite clearance. * To evaluate the safety and tolerability of OZ439/FQ in adults and children. * To characterize the pharmacokinetics of OZ439 in plasma, FQ and its active metabolite SSR97213 in blood. * To determine the blood/plasma ratio for FQ and SSR97213 in some participants at limited time points in selected sites.
Detailed description
Total duration was 63 days for each participant.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ferroquine SSR97193 | Pharmaceutical form:Capsules Route of administration: oral |
| DRUG | Artefenomel | Pharmaceutical form:Granules for suspension Route of administration: oral |
| OTHER | Placebo | Capsules. Placebo capsules were used to keep the same number of capsules in each weight band while keeping the ferroquine dose blinded. No participant received placebo only. |
Timeline
- Start date
- 2015-07-25
- Primary completion
- 2019-09-23
- Completion
- 2019-09-23
- First posted
- 2015-07-14
- Last updated
- 2022-03-24
- Results posted
- 2020-10-19
Locations
12 sites across 7 countries: Benin, Burkina Faso, Gabon, Kenya, Mozambique, Uganda, Vietnam
Source: ClinicalTrials.gov record NCT02497612. Inclusion in this directory is not an endorsement.